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Tablets & Capsules May 2019 35 actively manage equipment maintenance, reducing unnecessary downtime. Disposable technology Many companies in the pharmaceutical industry are increasingly adopting disposable technologies, including SBVs, as a way to reduce costs by minimizing the han- dling of contaminated items as well as washing and clean- ing activities. Disposable SBVs are an economical alterna- tive to traditional containment valves and are increasingly being used in SODF manufacturing, but their perfor- mance must be equal to their reusable equivalent to avoid sacrificing the health and safety of workers. Conclusion Achieving containment in manufacturing processes handling HPAPIs can be challenging, but it is critical for both worker safety and regulatory compliance. Integrating disparate processing technologies from differ- ent suppliers into a single, contained production line is a highly complex task. Containment valves create common interfaces between the different technologies, providing a cost-efficient and flexible means of ensuring contain- ment. In addition, wireless monitoring offers manufactur- ers an automatic and reliable risk control method, ensur- ing that the valves perform as they should and that workers handling potentially hazardous APIs are safe. T&C References 1. www.futuremarketinsights.com/reports/oral- solid-dosage-pharmaceutical-formulation-market. 2. www.grandviewresearch.com/industry-analysis/ hormone-replacement-therapy-market. 3. www.grandviewresearch.com/industry-analysis/ high-potency-active-pharmaceutical-ingredients-hpa pi-market. 4 . w w w . e p m m a g a z i n e . c o m / o p i n i o n / a - f r e s h - perspective-on-oral-solid-dosage-forms/. 5. www.fda.gov/downloads/Drugs/DevelopmentApp rovalProcess/SmallBusinessAssistance/UCM456367.pdf. 6. www.aih a.o rg/aih ce07/h an d o u ts/p o 129racz kowski.pdf. Michael Avraam is the head of solutions engineering at ChargePoint Technology (+44 0151 728 4500, www. thechargepoint.com). Avraam is responsible for consulting with senior process specialists at global pharmaceutical facilities, OEMs, and engineering organizations in the US, Europe, and Asia, to review, support, and identify appropriate process con- tainment solutions and process requirements. He has more than 20 years of experience in the pharmaceutical industry and holds a bachelor's degree in mechanical engineering. Effective maintenance and operational performance monitoring are also important parts of any containment strategy. Monitoring the integrity of a containment valve using wireless technology enables maintenance, health and safety, and compliance teams to analyze performance data and make informed decisions about how to proac- tively manage their maintenance programs. The modular nature of wireless monitoring technolo- gies means that they can easily accommodate changes to manufacturing setups. Wireless monitoring also provides real-time reporting and data monitoring at a lower cost than manual monitoring. Operator intervention and potential exposure During solid dose production with HPAPIs, it's important to ensure full operator safety and minimize lev- els of environmental contamination. Countering the risks associated with human intervention is difficult, and con- tainment mustn't affect equipment operation or produc- tivity. Appropriate validation testing must accurately reflect the operator intervention. However, some aspects of performance can be reliant on operator technique, which further increases variability. Decontamination and cleaning of process equipment, from milling to tablet compression, must also be carried out in a contained manner. SBVs can be fitted with inte- grated washing devices to maintain containment during the washing phase. Preventative maintenance Frequent monitoring and regular preventative mainte- nance help to ensure reliable operation of containment equipment. Manufacturers can minimize risk by immedi- ately rectifying any damage that occurs during operation. Wireless technology enables manufacturers to maxi- mize up-time by maintaining product integrity. It increases operator safety and ensures optimal perfor- mance and productivity. The real-time feedback pro- vided by wireless monitoring allows companies to pro- Monitoring the integrity of a containment valve using wireless technology enables maintenance, health and safety, and compliance teams to analyze performance data and make informed decisions about how to proactively manage their maintenance programs.